# K041879: Palomar LUX1064 Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Jan 13, 2005 after 185 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
416 later devices descend from it; 5 cite it directly.
0 of 417 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) StarLux™ Pulsed Light System (handpieces): named in the summary without a submission number
- (no number) Lumenis Family of IPL & IPL/NdYAG: named in the summary without a submission number
- (no number) Candela GentleYAG: named in the summary without a submission number
- (no number) Laserscope LLRA: named in the summary without a submission number
- (no number) Laserscope Lyra series: named in the summary without a submission number

## Most influential descendants
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own

## Indications for use
The Lux 064TM handpiece is indicated for: • The removal of unwanted hair for skin types J-VI, and to effect stable long-term permanent hair reduction. • The treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, ehloasma, caf&-au-Iait macules, and plaques. • Verrucae, skin tags, seborrheic keratosis. • Tattoos (significant reduction in the intensity of black and/or blue-black tattoos). • The Lux1064T M is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from'aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments. The treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins. • The LuxL064 TM is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. • Coagulation and hemostasis of soft tissue. • Treatment of wrinkles. • Pseudofolliculitis barbae (PFB)

Source page: https://510kreport.com/device/K041879
Methodology: https://510kreport.com/methodology